Body Parameters as an Independent Predictor of Acute Pancreatitis

• ClinicalTrials.gov Identifier: NCT03482921
• Recruitment Status: Completed
• First Posted: March 29, 2018
• Last Update Posted: March 29, 2018
• Sponsor: Ningbo No. 1 Hospital
• Information provided by (Responsible Party): Ningbo No. 1 Hospital

Tracking Information

• First Submitted Date: March 23, 2018
• First Posted Date: March 29, 2018
• Last Update Posted Date: March 29, 2018
• Actual Study Start Date: December 1, 2017
• Actual Primary Completion Date: February 12, 2018 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: March 23, 2018)

• Comparisons of variables according to AP severity [ Time Frame: the physical examination data in the year of 2017 ]
  Comparisons of variables according to AP severity by one-way analysis of variance (ANOVA) and Likelihood Ratio
• Relationships between VAT and severity outcomes Relationships between VAT and severity outcomes Relationships between VAT and severity outcomes Relationships between body parameters and severity outcomes [ Time Frame: the physical examination data in the year of 2017 ]
  Relationships between VAT and severity outcomes by Likelihood Ratio

• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Body Parameters as an Independent Predictor of Acute Pancreatitis
• Official Title: Body Parameters as an Independent Predictor of Acute Pancreatitis: A Propensity Score-matched Case-control Study
• Brief Summary: This study is to assess the predictive significance of visceral adipose tissue (VAT) and visceral adipose tissue /skeletal muscle tissue ratio (VAT/SMT ratio) for the prognosis in acute pancreatitis (AP) patients.

Detailed Description

Acute pancreatitis (AP) is a sudden inflammation of the pancreas. However, one-fifth of patients may develop severe complications with a mortality between 10%-20% It remains a difficulty to find an effective method for prediction of severity of AP at early stage.

It is well-established that obesity (defined as body mass index[BMI]>30kg/m2 by the World Health Organization) is a risk factor for AP and increases the incidence of systemic complication, motality. There are a lot of parameters related to saropenic obesity, including areas of visceral adipose tissue (VAT), subcutaneous adipose tissue (SAT), skeletal muscle tissue (SMT), and VAT/SMT ratio. it is unclear which parameter is the best predictor of severe AP. Thus, this study is aimed to investigate the association between these parameters and AP severity and find the best predictor of AP.

• Study Type: Observational [Patient Registry]
• Study Design: Observational Model: Case-Control; Time Perspective: Cross-Sectional
• Target Follow-Up Duration: 7 Years
• Biospecimen: Not Provided
• Sampling Method: Non-Probability Sample
• Study Population: Diagnosis criteria for AP was defined as the presence of at least 2 of the 3 following factors: (1) abdominal pain characteristic of AP; (2) serum amylase and/or lipase levels≥3 times the upper limit of the normal level, and (3) characteristic findings of AP on a CT scanning.
• Condition: Acute Pancreatitis
• Intervention: Not Provided
• Study Groups/Cohorts: Not Provided
• Publications *: Xie J, Xu L, Pan Y, Li P, Liu Y, Pan Y, Xu L. Impact of visceral adiposity on severity of acute pancreatitis: a propensity score-matched analysis. BMC Gastroenterol. 2019 Jun 13;19(1):87. doi: 10.1186/s12876-019-1015-z.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: March 23, 2018): 1662
• Original Actual Enrollment: Same as current
• Actual Study Completion Date: March 22, 2018
• Actual Primary Completion Date: February 12, 2018 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

1. diagnosed with AP
2. age >18 years

Exclusion Criteria:

1. age<18years
2. missing data in the electronic medical record
3. history of AP

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 100 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: Not Provided
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: China

Administrative Information

• NCT Number: NCT03482921
• Other Study ID Numbers: Ningbo4
• Has Data Monitoring Committee: Not Provided

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

• IPD Sharing Statement: Not Provided
• Responsible Party: Ningbo No. 1 Hospital
• Study Sponsor: Ningbo No. 1 Hospital
• Collaborators: Not Provided

Investigators

• Principal Investigator: Lei Xu, Dr; Department of gastroenterology, Ningbo No.1 Hospital, Ningbo, China

• PRS Account: Ningbo No. 1 Hospital
• Verification Date: March 2018